Outcomes of Swallowing Rehabilitation After Stroke

Completed

Phase N/A Results N/A

Trial Description

This project proposes to evaluate the relative effectiveness of four therapy protocols for pharyngeal phase swallowing impairment in the stroke population. Data derived from this study should contribute significantly to our understanding of the rehabilitative process in the neurogenic dysphagic population and will provide the foundation for the establishment of efficacious, cost-efficient patient services.
1. Research Question to be addressed
1. The utilization of SEMG biofeedback monitoring in dysphagia rehabilitation facilitates more rapid and complete recovery than traditional rehabilitation using the same swallowing exercises without exteroceptive feedback.
2. Swallowing rehabilitation provided in an intensive rehabilitative programme (10 hrs of treatment in the 1st week) facilitates more rapid and complete recovery than traditionally scheduled swallowing rehabilitation (twice weekly).

Detailed Description

This multi-site, multi-national project will evaluate the relative effectiveness of four therapy protocols for pharyngeal phase swallowing impairment in the stroke population. For this study, patients with chronic dysphagia secondary to stroke will be assigned to one of four treatment protocols. These four protocols differ in respect to the intensity of treatment and the inclusion of surface electromyography (SEMG) biofeedback as an adjunct to treatment. All patients will complete a total of 30 hours of therapy with data collection to assess progress at intervals of every 10 sessions. Treatment outcomes will be measured using a combination of physiologic and behavioral measures. Data derived from this study should contribute significantly to our understanding of the rehabilitative process in the neurogenic dysphagic population and will provide the foundation for the establishment of efficacious, cost-efficient patient services.

Conditions

Interventions

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary The following outcomes measures will be assessed after 10. 20 and 30 therapeutic sessions:
Primary Severity rankings of swallowing pathophysiology based on videofluoroscopic swallowing studies Videofluoroscopic swallowing studies
Primary Functional outcome ratings of associated clinical parameters (respiratory, neurological status, self help, cognitive)
Primary Quality of life ratings (SwalQOL) In addition, quality of life ratings (SwalQOL) will be assessed at one follow-up assessment six months post discharge.

Sponsors